What is meaning of OEM in medical device industry?
OEM means original equipment manufacturer in medical device industry. But coming to regularly pronounced medical device industry terminology it is misleading. OEMs are manufacturers who... Read More
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What is pediatric exclusivity?
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a patent but need not do... Read More
What is meaning of Common Technical Document (CTD)?
The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines. And it is designed to be used... Read More
What is the meaning and significance of ‘First to File’ Generics?
The first to file generics submits a substantially completed Abbreviated New Drug Application to receive marketing exclusivity for 180 days. Let us understand the concept... Read More
What is a CDMO?
A Contract Development and Manufacturing Organization (CDMO) serves clients various services from drug development to contract manufacturing. Services offered by CMOs include, but are not limited... Read More
What is the difference between Market withdrawal and Product Recall?
Posted on04 Dec 2023
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Product Recalls are actions taken by a firm to remove a product from the market. by FDA request, or by FDA order, whereas Market withdrawal... Read More
What is difference between phase IIa and Phase IIb clinical trial?
Posted on04 Dec 2023
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Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how much drug should... Read More
What is PIC/S? Is India part of PIC/S?
Posted on04 Dec 2023
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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal... Read More
What is the difference between purity and potency?
Posted on04 Dec 2023
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Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes... Read More
What are DACH region? Which countries are part of DACH region?
Posted on04 Dec 2023
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The DACH region is part of Europen. DACH region comprises of Austria, Germany, and Switzerland. DACH countires are basically German Speaking Countries. DACH is an acronym... Read More
What is difference between New Drug Application and Marketing Authorization Application?
Posted on04 Dec 2023
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Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), obviously finalized... Read More